Dr. Welslau on Acceptance of Rituximab Biosimilar in DLBCL

Manfred Welslau, MD
Published: Tuesday, Aug 27, 2019



Manfred Welslau, MD, Internal Medicine, Hematology and Oncology, Onkologie Aschaffenburg, discusses the growing acceptance of a rituximab (Rituxan) biosimilar in the treatment of patients with diffuse large B-cell lymphoma (DLBCL), following favorable results from a safety analysis of the REFLECT study.

In Europe, the biosimilar sandoz rituximab (SDZ-RTX) has received approval for the same indications as reference rituximab (Rituxan) based on the totality of evidence for biosimilarity. REFLECT, the first post-approval rituximab biosimilar study to be done in DLBCL, aims to evaluate the use of the rituximab biosimilar in patients with treatment-naïve CD20-positive disease as curative therapy.

Data from an interim analysis of the study presented at the 2019 ASCO Annual Meeting showed that of the 80 patients evaluated in the trial, most experienced little to no restriction in daily activities. B-symptoms were reported in 15 patients, extranodal infiltration was noted in 40 patients, and bulky disease was observed in 9 patients. However, these safety data were expected based on what has been seen with rituximab-based treatment.

Biosimilar use in non-curative treatment is largely accepted, but acceptance regarding the use of these products in the curative setting is pending. Welslau hopes that data from the REFLECT trial will encourage more acceptance of these products in the treatment of this population as the study continues.

Proving the process behind the development of SDZ-RTX is what will be necessary in order to gain approval for the agent worldwide. Welslau adds that the charge variants of rituximab are already changing and sandoz rituximab is just another charge.
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Manfred Welslau, MD, Internal Medicine, Hematology and Oncology, Onkologie Aschaffenburg, discusses the growing acceptance of a rituximab (Rituxan) biosimilar in the treatment of patients with diffuse large B-cell lymphoma (DLBCL), following favorable results from a safety analysis of the REFLECT study.

In Europe, the biosimilar sandoz rituximab (SDZ-RTX) has received approval for the same indications as reference rituximab (Rituxan) based on the totality of evidence for biosimilarity. REFLECT, the first post-approval rituximab biosimilar study to be done in DLBCL, aims to evaluate the use of the rituximab biosimilar in patients with treatment-naïve CD20-positive disease as curative therapy.

Data from an interim analysis of the study presented at the 2019 ASCO Annual Meeting showed that of the 80 patients evaluated in the trial, most experienced little to no restriction in daily activities. B-symptoms were reported in 15 patients, extranodal infiltration was noted in 40 patients, and bulky disease was observed in 9 patients. However, these safety data were expected based on what has been seen with rituximab-based treatment.

Biosimilar use in non-curative treatment is largely accepted, but acceptance regarding the use of these products in the curative setting is pending. Welslau hopes that data from the REFLECT trial will encourage more acceptance of these products in the treatment of this population as the study continues.

Proving the process behind the development of SDZ-RTX is what will be necessary in order to gain approval for the agent worldwide. Welslau adds that the charge variants of rituximab are already changing and sandoz rituximab is just another charge.

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